Z-3162-2011

Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation...

Name: Z-3162-2011 Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation...
Creator: Orthofix, Inc.
Published: 2011-04-01
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2011-04-01 / Terminated / root cause: design

FDA source

Orthofix, Inc. began a recall of Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD... on 2011-04-01. The reason FDA records is "Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3162-2011
Status: Terminated
Initiated: 2011-04-01
Posted: 2011-09-07
Terminated: 2012-03-23
Recalling firm: Orthofix SRL
Product: Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD Instrument Case. Product is intended for use with the Set Screw Driver (52-1061) and Adjustable Counter Torque Wrench (52-1265) to perform the final tightening of set screws in a spinal implant construct.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse.
Root cause tag: design
FDA root cause: Device Design
Action: Orthofix, Inc. sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated April 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove the affected product from use. Customers were advised to use the combination of the Ratching R Handle and the Set Screw Driver if they experience problems with the Ratching Torque Limiting Handle. A Tracking and Verification form was attached for customers to complete and return to the Orthofix Inc. Regulatory Affairs Department via fax at 214-937-3322. Contact your Account Services Representative at 888-298-5700 for questions regarding the removal and return of the affected product.
Quantity in commerce: 287 units
Distribution: Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia and Germany.
Product codes and lots: All serial numbers.

Product code NKB

K092624Class IIFirebird Spinal Fixation SystemBlackstone Medical, Inc. / cleared 2009-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)